Kids' Multi-symptom Cold And Flu

Kids' Multi-symptom Cold And Flu
SPL v2
SPL
SPL Set ID 2d918ec8-3098-1d09-e063-6294a90a9e8f
Route
ORAL
Published
Effective Date 2025-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Acetaminophen (320 mg)
Inactive Ingredients
Agave Tequilana Juice Water

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-31
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if your child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Indications and Usage

Uses

  • temporarily reduces fever and relieves these common cold/flu symptoms:
  • minor aches & pains
  • headache
  • cough due to minor throat and bronchial irritation
  • sore throat

  • controls the impulse to cough to help your child get to sleep
Dosage and Administration

Directions

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see Overdose warning)
  • SHAKE WELL before each use
  • find right dose on chart below
  • for accurate dosing, use measuring cup provided. Do not use with any other dosing device.
  • give dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
children 6 to under 12 years 10 mL every 4 hours
children 4 to under 6 years 7.5 mL every 4 hours
children under 4 years do not use

Description

Drug Facts

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms.

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • store between 20-25°C (68-77°F)
  • do not refrigerate
Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if

  • pain or cough gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

Section 50567-7

When using this product do not use more than directed

Section 50568-5

Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if the child has

  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus).
Section 50570-1

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Section 51727-6

Inactive ingredients

organic agave syrup, organic blueberry flavor, natural flavors, purified water

Section 51945-4

Genexa ®

MEDICINE MADE CLEAN

Ages 4+

Kids' Multi-Symptom Cold & Flu

Acetaminophen - Pain Reliever/Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Fever

Headache

Sore Throat

Cough

Body Aches & Pains

0% Artificial Additives

Always free of common allergens, artificial preservatives, flavors, & dyes

Organic Blueberry Flavor

4 fl oz (118 mL)

Section 53413-1

Questions? 1-855-436-3921

Section 55105-1

Purposes

Pain reliever/fever reducer

Cough suppressant

Section 55106-9

Active ingredients

(in each 10 mL)

Acetaminophen 320 mg

Dextromethorphan HBr, USP 5 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily reduces fever and relieves these common cold/flu symptoms:
  • minor aches & pains
  • headache
  • cough due to minor throat and bronchial irritation
  • sore throat

  • controls the impulse to cough to help your child get to sleep
Dosage and Administration (34068-7)

Directions

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see Overdose warning)
  • SHAKE WELL before each use
  • find right dose on chart below
  • for accurate dosing, use measuring cup provided. Do not use with any other dosing device.
  • give dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
children 6 to under 12 years 10 mL every 4 hours
children 4 to under 6 years 7.5 mL every 4 hours
children under 4 years do not use

Warnings and Precautions (34071-1)

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if your child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms.

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • store between 20-25°C (68-77°F)
  • do not refrigerate
Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • pain or cough gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product do not use more than directed

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if the child has

  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus).
Section 50570-1 (50570-1)

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Section 51727-6 (51727-6)

Inactive ingredients

organic agave syrup, organic blueberry flavor, natural flavors, purified water

Section 51945-4 (51945-4)

Genexa ®

MEDICINE MADE CLEAN

Ages 4+

Kids' Multi-Symptom Cold & Flu

Acetaminophen - Pain Reliever/Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Fever

Headache

Sore Throat

Cough

Body Aches & Pains

0% Artificial Additives

Always free of common allergens, artificial preservatives, flavors, & dyes

Organic Blueberry Flavor

4 fl oz (118 mL)

Section 53413-1 (53413-1)

Questions? 1-855-436-3921

Section 55105-1 (55105-1)

Purposes

Pain reliever/fever reducer

Cough suppressant

Section 55106-9 (55106-9)

Active ingredients

(in each 10 mL)

Acetaminophen 320 mg

Dextromethorphan HBr, USP 5 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:40.555950 · Updated: 2026-03-14T23:11:23.873993